Argument preview: Patients’ reaction, patents’ scope

Posted Sat, December 3rd, 2011 12:44 am by Lyle Denniston

At 10 a.m. next Wednesday, the Supreme Court will hold one hour of oral argument on Mayo Collaborative Services, et al., v. Prometheus Laboratories (10-1150), a test case on the scope of patent rights for a method of gauging medical patients’ reaction to drug dosages. Representing the Mayo organizations will be Stephen M. Shapiro of the Chicago office of Mayer Brown LLP, with 25 minutes of argument time. Richard P. Bress of the Washington, D.C., office of Latham & Watkins LLP, also with 25 minutes of time, will argue for Prometheus. Between the two of them, U.S. Solicitor General Donald B. Verrilli, Jr., will speak for the federal government as an amicus. The government will have its own 10 minutes at the lectern, since it does not support either side; it favors patent eligibility for the diagnostic method at issue but raises an issue of whether the patent on the method is nonetheless invalid for other reasons.

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For the past two years, the Supreme Court has been pondering the implications of a federal appeals court’s formula for judging when an inventor is entitled to a patent, a core issue in patent law. In the midst of that examination, the Justices have twice confronted a complex case of major importance to the medical profession and to the pharmaceutical industry, as well as to patent lawyers generally. On its second trip to the Court, the case might produce a sweeping new decision on the right to gain a monopoly over a medical diagnostic technique, or it might end with at least a hint that the specific patent in dispute is simply invalid because it may not be enough of a new invention.

The Washington-based specialized appeals court that reviews patent disputes, the U.S. Circuit Court for the Federal Circuit, in 2008 devised what it said was the exclusive test on whether a claimed invention is eligible for a patent under Section 101 of the federal Patent Act. That section is the first barrier an inventor must clear in hopes of getting a patent. The Federal Circuit said that an invention either had to be tied to a machine or apparatus, or it had to transform an article into a different state or thing. That thus was known as the “machine-or-transformation” test. The Justices, in the 2010 ruling in Bilski v. Kappos, said the test could be a useful one, but it was not the sole test.

After the Bilski ruling, the Justices concluded that the decision likely had an impact on a case pending before them, Mayo Collaborative Services, et al., v. Prometheus Laboratories (docket 09-490), in which the Federal Circuit had used its exclusive test. So the Justices sent that case back to the Federal Circuit for another look. The case returned to the Supreme Court, under the same name (but a different docket number, 10-1150), after the Federal Circuit again upheld the patent at issue, finding that it satisfied the “transformation” test.

There is a sharp dispute between the way that the diagnostic technique at issue is described by the two sides in the Mayo case. The famous Mayo Clinic and affiliated organizations argue that it is simply a medical judgment call that has been “familiar to physicians for decades”: they give a patient a given dosage of a specific drug, and gauge the patient’s reaction, and repeat the process if necessary with different dose levels. Prometheus Laboratories, the exclusive holder of a license to use the patent at issue (the patent is owned by a Canadian company), claims it is a sophisticated method of gauging how a particular line of drugs (“thiopurines”) are transformed inside the human body when administered at varying dosage levels.

For perhaps a half-century, doctors have been using thiopurines to treat gastrointestinal disorders, such as Crohn’s disease, that result from abnormalities in the body’s immune system — the ability to fight off “outside” agents in the body. The main versions of this class of drugs have been found also to aid in remission of leukemia as well as in treating some forms of colitis. In addition, they have been used to suppress immune systems that are seeking to reject transplanted organs.

The main versions of thiopurines suppress the immune reaction after a patient takes a dose, and the drug is converted by the body’s natural chemistry into various metabolites. Prometheus Laboratories holds the sole license to two U.S. patents that claim a method for measuring the concentration of the resulting metabolites in the patient’s blood. Because this line of drugs has a high potential to be toxic in humans, and an individual patient’s proper dose is difficult to gauge, some doctors were reluctant to prescribe thiopurines for their patients.

The invention at issue is embodied in a thiopurine metabolites test kit, “Pro-Predict,” which Prometheus sells to medical providers for use in treating gastrointestinal illnesses related to immune system function. If, in response to a given dosage of a thiopurine, a patient’s metabolites rise to a given level, the kit signals the doctor that a dosage adjustment is needed. Mayo’s clinic and hospital affiliates bought copies of the testing kit, but then the group decided to market its own test for gauging thiopurine dosages, with a slight variation from the Prometheus kit.

Prometheus sued for infringement on the two patents, but a federal judge threw out the patents. The judge concluded that the testing method simply involved the laws of nature and a doctor’s use of medical learning to gauge how a patient’s natural chemistry reacted to the dosage level. (Under patent law, natural phenomena cannot be patented, since they are open to everyone to examine and apply.) The patents, the judge found, simply gave Prometheus a monopoly on making the kind of correlations that doctors conventionally make.

In its first ruling, the Federal Circuit found that the two patents were patent-eligible under Section 101, because they involved a “transformation” — that is, the thiopurines are used to transform the body’s chemistry, with a medically useful result, the metabolite reading. That was the result the Supreme Court set aside in 2010, leading to the Federal Circuit’s reaffirmation in December 2010. The two rulings dealt only with patent eligibility under Section 101, and thus did not address whether the two patents in dispute could satisfy other requirements of patent law.

Petition for Certiorari

Arguing that the case was a test of “whether a patentee can monopolize basic, natural biological relationships,” the Mayo groups took the case on to the Supreme Court last March. The petition raised a single question under Section 101: whether a claim that “preempts all uses of the naturally occurring correlations” in patient care is eligible for a patent simply because the normal methods of giving drugs and testing blood may involve a “transformation” through body chemistry. If that claim is worthy of a patent, the petition contended, there is no way for the courts to prevent patent drafters from using a “trick” in describing their claims that give the inventor a monopoly over basic medical knowledge.

“If Prometheus’s patents are allowed to stand,” the petition asserted, “doctors will no longer be free to consider this biological phenomenon in treating patients or in attempting to develop new treatments for diseases.” The Prometheus method, it argued, “far from constituting innovation,” involves “nothing more than the body’s natural reaction to the ingestion of drugs, and a mental recognition of that natural reaction.”

The Mayo group sought to bolster its plea for review by noting that the Justices had agreed to review a very similar dispute five years ago, but wound up dismissing that case because the issue was not properly raised (Laboratory Corp. of America v. Metabolite Laboratories, 2006). The petition also noted that three Justices, in dissent from the dismissal of that case, warned about patents on medical knowledge that were too open-ended. (The dissenters spoke through an opinion by Justice Stephen G. Breyer. He was joined by two Justices no longer on the Court, David H. Souter and John Paul Stevens.) The petition also noted that many amici in the Lab Corp. case “stressed that patents like Prometheus’s frustrate improvements in healthcare, drive up costs, and freeze innovation.”

Moreover, it said, the U.S. Patent Office has been granting patents on medical correlations at an increased rate, threatening public health.

Prometheus, seeking to head off Supreme Court review, offered a sturdy defense of the invention, saying that “the claims here describe concrete and improved methods of treating seriously ill patients and involve the administration and biochemical transformation of specified synthetic drugs.” The case was “straightforward and fact-bound,” the company contended, adding that the Federal Circuit ruling was “unremarkable and perfectly consistent with this Court’s precedent.”

The response contended that the Mayo group’s petition had distorted the facts of the case, and the scope of the Federal Circuit ruling. It also argued that the Mayo petition had sought to raise issues other than the scope of Section 101, and stressed that nothing was involved but that provision.

Moreover, it said that the Court’s decision in the Bilski case, on patent eligibility, provided a recent “synthesis” of the law on Section 101’s scope, and the lower courts should be given an opportunity to explore what that guidance means before the Justices themselves returned to the issue.

A wide array of medical and research organizations, arguing about the potentially widespread impact they saw in the Federal Circuit ruling, joined Mayo in urging the Justices to take on the case.

The Court granted review on June 20, and the case is now set for argument on December 7.

Merits Briefs

The case, at the merits briefing stage, partly retained its character as a contest over patenting supposedly natural phenomena versus patenting true medical innovation, but it may well have been transformed in two ways by the federal government’s decision to join in the case. If the U.S. Solicitor General’s positions are found persuasive by the Justices, the case could more easily become a significant new interpretation of what it takes to create a patentable invention. The government made a strenuous effort to protect Section 101 as a more welcoming provision for new inventions. At the same time, however, the government cast a serious doubt on whether the two patents at issue deserved a patent in the first place. That raised the prospect that anything the Court might say on Section 101 might be little more than an advisory opinion — something the Justices are not supposed to hand down.

Before getting to those potential recastings of the case and their import, the feud between the two direct legal combatants is worth examining.

The Mayo group’s merits brief contended that the case involved nothing less than the need for the Court to reaffirm the “basic principle” that the “fundamental tools of discovery must be available to all for use in developing new and better inventions,” and then to apply that reaffirmed tenet “in the context of medical patents covering natural phenomena.” And, on the first page of the document, it sought immediately to exploit the expression of Justice Breyer’s fears five years ago about doctors being barred from “using their best medical judgments,” and being forced into spending “unnecessary time and energy to enter into license agreements” in order to conduct their practice.

Next, the brief moved into an analysis of blood testing for metabolites, in an obvious effort to bolster its claim that Prometheus was trying to lock up in a monopoly the use of medical judgment that has been common for decades. As one might expect from a widely respected medical organization, the Mayo brief sought to show how doctors make case-by-case judgments, using their professional learning, that are “critical to patient health.”

In the brief’s legal argument sections, it stressed the breadth of medical techniques that it argued would be encompassed by the sweep of the Prometheus patents, and the purported inability of Prometheus to defend its patents on the premise that it involves some special process of analysis apart from practices long prevalent among doctors. In addition, it argued that, when Congress wrote the present version of Section 101 in 1952, it would have been “unthinkable” that the patent laws could be used to “embargo independent research and thought about a natural correlation.” Finally, it suggested that the Court keep in mind that a patent’s validity is often put into question when it becomes apparent that it will have a negative impact on “innovation and competition.”

Prometheus’s brief on the merits sought initially to answer directly the Mayo claim that the disputed patents were an attempt to lock up a natural phenomenon, involving mere abstract ideas. Section 101, it noted, does not allow patents that would attempt to monopolize those phenomena, and insists that an invention be a genuine process that involves “a series of steps that involve physical action in the real world,” and requires that the claims be sufficiently specific that they do not “preempt abstract ideas or basic building blocks of science.”

The invention at issue, Prometheus contended, clearly fits within those limitations of Section 101. Likening the invention to the telegraph, which involves a patent on a process for using it rather than a claim to the abstract idea that information might be sent electrically over distances, Prometheus said the two patents embrace a process that employs drugs and machines, rather than simply making mental correlations between drugs and effects that a doctor might make in clinical observation.

“These patents,” its brief contended, “do not claim the abstract idea of calibrating drug doses by measuring metabolites or all ways of calibrating thiopurines.” Rather, it said, they claim and preempt only one “particular way to improve the treatment of patients suffering from certain diseases.” That, it summed up, “is precisely the sort of monopoly the patent system is meant to convey, not one of the basic building blocks of nature with which this Court’s preemption analysis is concerned.”

To Mayo’s expressed worries over the perceived threat to medical science and innovation, Prometheus offers its own grand-scheme argument, suggesting that the United States maintains its leadership in biotechnology and “personalized medicine” because “inventors have committed billions of dollars in capital in reliance on the prospect of patents” like those at issue here. In any event, it said, Congress has already considered and rejected the notion that there should be only limited patent protection for medical diagnosis and treatment methods.

There is a reasonably close volume of support from amici on opposite sides of the case, mostly tracking the lines of argument pursued by the two main combatants, and attempting to enhance the two sides’ broader claims that this case involved much more than a dispute about two specific patents.

The amicus filing that may well have the greatest impact on the Court, though, is the one filed by the federal government’s lawyers. From a strategic point of view, the Solicitor General’s brief is primarily a defense of Section 101 as an invitation to new inventions — so far as that section’s specific language goes. That provision of patent law, the brief contended, is meant to be only a “coarse filter,” crafted by Congress in broad terms to promote the Constitution’s goal of advancing “science and the useful arts.”

Initially siding with Prometheus on whether its “Pro-Predict” kit should be allowed to at least enter into the first stage of patent eligibility, the government brief contended that it involved “a classic patent-eligible process: it recites a series of acts, performed in the physical world, that transforms the subject of the process (the body chemistry of the patient) to achieve a useful result.” The fact that the “transformation” comes inside a human body, the brief added, does not put the invention beyond the patent law’s scope. “The patent laws,” it noted, “have long been understood to encompass improved methods of treating patients to alleviate medical disorders.”

Moreover, the Solicitor General’s filing said, the Prometheus patents do not preempt something from nature. They involve what happens when a specific kind of drug, thiopurine, is introduced into the human body, and the resulting “transformation” is natural only in the sense that “all drugs depend on the natural processes of the human body for their therapeutic effect,” according to the brief. “To treat that fact as a basis for denying patent protection,” it added, “would severely disrupt the operation of the patent laws.”

Having suggested that the inventor of the process should have been allowed in the door at the U.S. Patent Office, the government brief then went on to jump to Mayo’s side of the dispute. Other provisions of the patent law, specifically Sections 102 and 103, imposing other tests for patent issuance, the brief said, probably would work to block these two patents. Those two sections, it noted, “require that a patentable invention be both novel and non-obvious.” Mayo’s challenge, it argued, “has considerably more force” under those two sections. The brief then said flatly that Mayo’s “ultimate conclusion that the claims are invalid appears to be correct.”

The brief added only the caution that any such conclusion should rely only on the other sections of patent law, not on Section 101, because to do that would be to threaten future process inventions that do satisfy those other sections of the law. Section 101 is too broad a filter, it added, to provide the “nuanced, fact-intensive distinctions” that must be drawn under Sections 102 and 103 in order “to separate patentable from unpatentable inventions.”

In the end, the government brief suggested that the Court uphold the Federal Circuit’s ruling that the Prometheus process was patent-eligible, but it should not decide, at this stage, whether the patents should have been granted. If Mayo has preserved an argument that the “Pro-Predict” process was in some way not an advance over prior art or would have been obvious to those knowledgeable in the field, the Solicitor General’s brief said, the Federal Circuit Court can deal with that on remand.

Analysis

The federal government’s brief has given something of a policy, more than a legal, cast to the issue that the Court agreed to review: the scope of Section 101, at least as inventions arise in the field of medical diagnosis and treatment. While that brief sought to make a strong case for a broad reading of that provision, the real-world significance of the separate argument that the two patents are likely invalid creates some tension for the Court as it processes this case. There is, to be sure, a positive policy value in inviting more inventors to approach the Patent Office with their creations, but if many of them are doomed to a subsequent conclusion that they simply built on somebody else’s creation, and not in an innovative way, the pragmatic value of a broad Section 101 interpretation may be doubted.

The government, in fact, has introduced some tension of its own into its interpretive approach. On the one hand, it is pleading for a generous reading of Section 101, while advocating a more nuanced — one might say more stingy — interpretation of Sections 102 and 103. Is there a persuasive argument that the “progress of science and the useful arts” in the Constitution’s patent clause is better promoted by a wide open door at the front of the Patent Office, than by a difficult-to-negotiate labyrinth once inside? Has Congress, in fact, mandated such a conflicting reading of the separate sections of the law?

This case, in short, now looks to be either an interlocutory appeal, on a point that may not be dispositive in the end, or an invitation to the Justices to hand down an advisory opinion on one part of patent law, only to send Prometheus on to a conclusive defeat on the novelty and obviousness issue.

On the other hand, of course, the Justices may see in this case — as they apparently did five years ago in the Lab Corp. case — a fit occasion to say something of more general value about patent eligibility in the field of medical innovation. Obviously, this kind of dispute is arising with some regularity, and the Patent Office seems to be increasingly generous in granting patents in the medical field, and perhaps needs some helpful new guidance on whether it is doing things right. In recent years, the Court has had a lively interest in patent law, and it very likely has an interest in spelling out further the implications of its Bilski decision.

Further, given that the Court is quite sparing in the number of cases it is willing to hear and decide each Term, it understandably may not be fully comfortable taking a pass on a case it has taken on, with the legal — and perhaps cultural — stakes as high as they seem to be in the Mayo case.

Aug. 2015

In a conversation with Bill Kristol of The Weekly Standard, Justice Samuel Alito reflects upon (among other things) his arrival on the Court, recent First Amendment cases, the themes in his dissent in Obergefell v. Hodges, and his love for baseball.